Trials / Not Yet Recruiting
Not Yet RecruitingNCT07476105
Geriatric-guided Care Versus Conventional Care in Elderly Unfit/Frail Patients With Diffuse Large B-cell Lymphoma in First Line Treatment
Geriatric-guided Care Versus Conventional Care in Elderly Unfit/Frail Patients With Diffuse Large B-cell Lymphoma in First Line Treatment. The Elderly Project 2.0: Non-randomized Cluster Controlled Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- Sponsor
- Fondazione Italiana Linfomi - ETS · Academic / Other
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this multicenter, non-randomized, cluster controlled trial study is to evaluate the impact of a geriatric-guided approach with a pro-active rehabilitative/nutritional plan for elderly unfit/frail DLBCL patients eligible for receiving chemoimmunotherapy according to the sGA, versus a conventional approach with onco-hematological treatment alone. A key innovation element of this project is to use a geriatric-guided approach to improve the global management of all frailty aspects (nutritional, functional, cognitive, social), chasing a better tolerance and completion rate of treatment, tailoring safety and efficacy of therapies in unfit/frail DLBCL patients. This study may lead to a personalized approach for elderly DLBCL patients, taking into account a multidisciplinary and fully-integrated program, with the primary aim of improving the quality of life of patients and their families.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Geriatric-guided supportive care | Structured geriatric consultation, along with a nutritional and physiotherapy evaluation, before treatment initiation and with subsequent follow-up assessments aimed at optimizing comorbidity management, nutritional and functional status, along with treatment tolerance. |
| OTHER | Conventional supportive care | Supportive care will be delivered according to local clinical practice |
Timeline
- Start date
- 2026-05-01
- Primary completion
- 2028-11-01
- Completion
- 2029-05-01
- First posted
- 2026-03-17
- Last updated
- 2026-04-15
Locations
24 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT07476105. Inclusion in this directory is not an endorsement.